Photocure announces positive results of Phase 2B study evaluating Visonac in acne

12-Jun-2012 - Norway

Photocure ASA announced the results of the phase 2b study in acne with Visonac (methyl aminolevulinate 80mg/g), a topical acne treatment. In this study, Visonac showed a statistically significant reduction in inflammatory lesions and overall improvement in acne severity.

The phase 2b trial was a multicenter randomized, double-blind, placebo controlled study in patients with severe acne vulgaris. The study included 153 patients enrolled at 15 office based dermatology practices and hospitals in the US. Patients were randomized to receive Visonac topically followed by red light illumination or vehicle cream followed by red light illumination (Control). The treatment regimen consisted of four treatments which were each administered two weeks apart. Efficacy and safety were assessed six weeks after the last treatment. The primary efficacy end-point in the study, reduction of inflammatory acne lesions, was achieved.

In patients treated with Visonac, a statistically significant reduction in inflammatory acne lesions of 43.8% was achieved as compared to 26.6% in the control group (p=0.003). Secondary efficacy end-points in the study included assessment of global acne severity, as measured by a standardized Investigator’s Global Assessment score (IGA). Visonac demonstrated improvement in overall acne severity in a significant percentage of patients as compared to control, 44.0% versus 26.4% (p=0.013), respectively. A significant and comparable reduction in non-inflammatory lesions was achieved in both groups.

Visonac was well tolerated and no serious adverse events were reported in the study. Among patients that received Visonac, a higher number experienced local transient pain during illumination. Additionally, post treatment erythema was reported more frequently in the Visonac arm (89% versus 70%), which most commonly subsided by the following day. Twelve patients withdrew from the study due to adverse events.

https://www.bionity.com/en/news/138248/photocure-announces-positive-results-of-phase-2b-study-evaluating-visonac-in-acne.html